(50 days)
The Tango+ is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, and percentage of oxygen saturation in arterial blood (SpO2) in adult patients during stress tests.
The SunTech Medical Tango+ Pulse Oximeter and NIBP monitor is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult patients in hospitals, medical facilities, and subacute environments.
1 11e Tango+, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test sytems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango+ has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.
The provided 510(k) submission document for the SunTech Medical Inc. Tango + System largely focuses on demonstrating substantial equivalence to predicate devices and adherence to electrical safety and electromagnetic compatibility standards, with less detail on the specific clinical study design and results for establishing acceptance criteria for device performance.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that the SpO2 system was validated in a clinical test but does not provide specific numerical acceptance criteria for either blood pressure or oxygen saturation, nor does it present the quantitative results of these clinical tests. It only broadly states that the device "will have passed" several non-clinical tests and that the SpO2 system was "thoroughly tested" and "validated in a clinical test."
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Blood Pressure | Not Specified (Implied adherence to ANSI/AAMI SP10) | Not explicitly reported in the provided text. |
| Oxygen Saturation (SpO2) | Not Specified | Stated as "thoroughly tested" and "validated in a clinical test." No quantitative results provided. |
| Electrical Safety | EN 60601-1 | Stated to have passed. |
| Electromagnetic Compatibility (EMC) | EN 60601-1-2 | Stated to have passed. |
| Biocompatibility | Not Specified | Stated that components "have had biocompatibility tests." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "The SpO2 system was validated in a clinical test." However, it does not provide any information regarding:
- The sample size used for this clinical test.
- The country of origin of the data.
- Whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document for either the blood pressure or SpO2 validation.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
A MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on the device's standalone performance and its equivalence to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the information provided strongly suggests that a standalone performance evaluation was conducted, particularly for the SpO2 system. The statement "The SpO2 system was validated in a clinical test" implies evaluating the device's inherent measurement capabilities. For blood pressure, the direct reference to ANSI/AAMI SP10 suggests a standalone performance evaluation against the requirements of that standard.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for either blood pressure or SpO2 measurements in the validation studies.
- For blood pressure, given the common practice for non-invasive blood pressure devices, the ground truth would typically be invasive arterial pressure measurements or auscultation by trained observers (double auscultation with a mercury sphygmomanometer) as per standards like ANSI/AAMI SP10.
- For SpO2, the ground truth for validation studies usually involves co-oximetry (arterial blood gas analysis) to directly measure fractional oxygen saturation in arterial blood, often under controlled desaturation conditions.
8. The Sample Size for the Training Set
The document does not provide any information on a training set or its sample size. This is typical for a 510(k) submission unless the device involves complex machine learning algorithms that require explicit training and validation sets. The Tango+ System appears to be based on established physiological measurement principles (Korotkoff sounds for BP, optical finger sensor for SpO2) rather than a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, this information is not applicable/not provided.
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K 053209
SunTech Medical Inc. 510(k) Submission Tango + System for Non-Invasive Blood Pressure and Per Cent Oxygen Saturation
510(K) Summary June 22, 2005
(1) Submitter information
| Name : | SunTech Medical Inc. |
|---|---|
| Address: | 507 Airport BoulevardMorrisville, NC 27560 |
| Telephone: | 1 919 654-2300 |
| Contact person: | David Gallick (Official Correspondent).SunTech Medical Inc.507 Airport BoulevardMorrisville, NC 275601 919 654 2332 |
June 22, 2005 Date prepared :
(2) Name of Device
| Trade Name: | Tango+ Automatic Blood Pressure and Oxygen Saturation MeasurementSystem |
|---|---|
| Common Name: | Automated Blood Pressure Monitor and Oxygen Saturation measurementdevice |
| Classification name: | System, measurement, blood pressure, non-invasive, systolic and/ordiastolic, 74JOE, 870.1130 |
(3) Legally-marketed predicate devices
SunTech Tango, K970629
Nonin Avant 2120, K031487
page 1 of 2
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Page 5-2
(3) Description
1 11e Tango+, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test sytems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango+ has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.
(4) Intended Use
The Tango+ is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, and percentage of oxygen saturation in arterial blood (SpO2) in adult patients during stress tests.
(5) Performance Data
(a) Non-clinical tests
The Tango+ will have passed the following tests:
- for Electrical Safety EN 60601-1 .
- l EN 60601-1-2 for Electromagnetic Compatibility ANSI/AAMI SP10
The oxygen saturation system has been thoroughly tested.
The components have had biocompatibility tests.
(b) Clinical tests
The SpO2 system was validated in a clinical test.
(6) Conclusion
The Tango+ Automated Blood Pressure and Oxygen Saturation Monitor system is equivalent in safety and efficacy to the legally-marketed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text around the perimeter is difficult to read due to the image quality, but it appears to be the name of a government agency or organization. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract look.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 5 2006
SunTech Medical, Inc. c/o Mr. David Gallick VP of Engineering 507 Airport Boulevard Morrisville, NC 27560
Re: K053209
Trade Name: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 09, 2005 Received: November 16, 2005
Dear Mr. Gallick:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. David Gallick
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimmarfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SunTech Medical
、
√(k) Number (if known): K053209
Indications for Use Form
Device Name: Tango+
Indications for Use:
The SunTech Medical Tango+ Pulse Oximeter and NIBP monitor is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult patients in hospitals, medical facilities, and subacute environments.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhimmer
n Sign-Off) Division of Cardiova 510(k) Nich ber
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).